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Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated With RSV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04540627
Recruitment Status : Completed
First Posted : September 7, 2020
Results First Posted : October 4, 2021
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
mAbxience Research S.L.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Other
Condition Healthy Adult Participants
Interventions Drug: Palivizumab
Drug: Placebo
Other: RSV-A Memphis 37b virus
Enrollment 56
Recruitment Details  
Pre-assignment Details

The study was conducted in 2 parts: Part 1 (PK sentinel part) and Part 2 (viral challenge part).

Part 1: Open-label. This part of the study was used to determine the dose of Palivizumab IV for Part 2 (8 or 15 mg/kg).

Part 2: Double-blind, randomized, and placebo-controlled. Participants received a single IV dose of either Palivizumab (8 mg/kg, as finally determined in Part 1) or a placebo and were subsequently challenged with an RSV-A strain.
Arm/Group Title Open-label Palivizumab (Part 1) Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Period Title: Open-label Treatment: PK Sentinel
Started 6 [1] 0 [2] 0 [2]
Completed 6 0 0
Not Completed 0 0 0
[1]
Participants were not enrolled in this arm in the double-blind period.
[2]
Participants were not enrolled in this arm in the open-label period.
Period Title: Double-blind Treatment: Viral Challenge
Started 0 [1] 25 [2] 25 [2]
Completed 0 25 25
Not Completed 0 0 0
[1]
Participants were not enrolled in this arm in the double-blind period.
[2]
Participants were not enrolled in this arm in the open-label period.
Arm/Group Title Open-label Palivizumab (Part 1) Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2) Total
Hide Arm/Group Description

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

 Total of all reporting groups
Overall Number of Baseline Participants 6 25 25 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 25 participants 25 participants 56 participants
25.67  (2.58) 28.16  (6.30) 26.76  (5.83) 26.86  (4.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 25 participants 25 participants 56 participants
Female
2
  33.3%
12
  48.0%
5
  20.0%
19
  33.9%
Male
4
  66.7%
13
  52.0%
20
  80.0%
37
  66.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 25 participants 25 participants 56 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   4.0%
1
   1.8%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
2
   8.0%
2
   3.6%
White
4
  66.7%
23
  92.0%
20
  80.0%
47
  83.9%
More than one race
2
  33.3%
2
   8.0%
2
   8.0%
6
  10.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Mean Serum Concentrations (Cmax) for Open-label Palivizumab (Part 1) on Day 12.
Hide Description

The PK assessment up to and including Day 12 exposure was used as a decision information for the dose to be given to participants in Part 2. Pharmacokinetic exposure data from at least 5 out of 6 participants were required for dose decision making with a projected exposure of ≥40 μg/mL on Day 12 according to the protocol.

This was achieved after administration of a single IV dose of Palivizumab at 8 mg/kg. Therefore, a dose of 8 mg/kg was chosen for Part 2.
Time Frame In Part 1: before the start of infusion; at end of infusion,15 minutes and 0.5, 1, 4, 8, and 12 hours after infusion; and at 1, 2, 3, 7, and 12 days after infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated had at least 1 post-dose PK result; therefore, all participants were included in the PK analysis population. One participant had an interrupted IV infusion of Palivizumab but received the complete dose of 8 mg/kg.
Arm/Group Title Open-label Palivizumab (Part 1) Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 6 0 0
Mean (Standard Deviation)
Unit of Measure: μg/mL
71.2  (6.11)
2.Primary Outcome
Title Area Under the Viral Load-time Curve (VL-AUC) as Determined by Polymerase Chain Reaction (qRT-PCR) on Nasal Samples, for Double-blind Palivizumab or Placebo (Part 2).
Hide Description RSV viral load of RSV-A Memphis 37b as determined by qRT-PCR on nasal samples collected twice daily: Assessment of the Area under the viral load-time curve (VL-AUC)
Time Frame From two days post viral challenge (Day 2) to the end of quarantine (Day 12) in Part 2 on nasal samples collected twice daily.
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable population includes 49 participants. All participants in this population received study intervention, were inoculated with challenge virus, and completed quarantine. One Palivizumab-treated participant was excluded from the evaluable population because the participant had not completed the quarantine period.
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 25 24
Mean (Standard Deviation)
Unit of Measure: Log10 copies*day/mL
11.68  (15.36) 9.94  (12.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-blind Placebo (Part 2), Double-blind Palivizumab (Synagis™) (Part 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5802
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title qRT-PCR Peak Viral Load for Double-blind Palivizumab or Placebo (Part 2).
Hide Description Peak viral load of RSV-A Memphis 37b as determined by qRT-PCR on nasal samples collected twice daily.
Time Frame From two days post viral challenge (Day 2) to the end of quarantine (Day 12) in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable population includes 49 participants. All participants in this population received study intervention, were inoculated with challenge virus, and completed quarantine. One Palivizumab-treated participant was excluded from the evaluable population because the participant had not completed the quarantine period.
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 25 24
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
3.66  (2.42) 3.11  (2.65)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-blind Placebo (Part 2), Double-blind Palivizumab (Synagis™) (Part 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4868
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Area Under the Viral Load-time Curve (VL-AUC) as Determined by Cell Culture on Nasal Samples, for Double-blind Palivizumab (Part 2).
Hide Description RSV Viral Load of RSV-A Memphis 37b as Determined by Cell Culture on Nasal Samples collected twice daily: Area under the viral load-time curve (VL-AUC) of RSV-A Memphis 37b
Time Frame From two days post viral challenge (Day 2) to the end of quarantine (Day 12) in Part 2 on nasal samples collected twice daily.
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Log10 PFU*day/mL
2.05  (5.29) 1.64  (3.43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-blind Placebo (Part 2), Double-blind Palivizumab (Synagis™) (Part 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2681
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Cell Culture Peak Viral Load for Double-blind Palivizumab or Placebo (Part 2).
Hide Description Peak Viral Load of RSV-A Memphis 37b as Determined by Cell Culture on Nasal Sample
Time Frame From Day 2 to Day 12 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 25 24
Mean (Standard Deviation)
Unit of Measure: Log10 PFU/mL
0.60  (1.47) 0.88  (1.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-blind Placebo (Part 2), Double-blind Palivizumab (Synagis™) (Part 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2431
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With Laboratory-confirmed Infection of RSV-A Memphis 37b in Nasal Samples (Variant 1) for Double-blind Palivizumab or Placebo (Part 2).
Hide Description

Percentage of Participants Infected Post-viral Challenge (Infectivity Status and Rate): occurrence of at least 2 positive "quantifiable" qRT-PCR measurements in nasal samples.

Laboratory-confirmed infection (variant 1): At least 2 positive quantifiable detections by viral load qRT-PCR assay specific for the challenge virus, reported within 4 consecutive scheduled assessments and from 2 independent samples from Day 2 until discharge and/or 1 positive detection by viral load qRT-PCR assay, specific for the challenge virus, in which an aliquot of the same sample has also tested positive in a viral culture assay appropriate for detecting the challenge virus from Day 2 until discharge.
Time Frame From Day 2 to Day 12 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 25 24
Measure Type: Count of Participants
Unit of Measure: Participants
13
  52.0%
12
  50.0%
7.Secondary Outcome
Title Number of Participants With Laboratory-confirmed Infection of RSV-A Memphis 37b in Nasal Samples (Variant 2), for Double-blind Palivizumab or Placebo (Part 2).
Hide Description

Percentage of Participants Infected Post-viral Challenge (Infectivity Status and Rate): Occurrence of at least 2 positive "detectable" qRT-PCR measurements in nasal samples.

Laboratory-confirmed infection (variant 2): At least 2 positive detectable assessments by viral load qRT-PCR assay specific for the challenge virus, reported within 4 consecutive scheduled assessments and from 2 independent samples from Day 2 until discharge and/or 1 positive detection by viral load qRT-PCR assay, specific for the challenge virus, in which an aliquot of the same sample has also tested positive in a viral culture assay appropriate for detecting the challenge virus from Day 2 until discharge.
Time Frame From Day 2 to Day 12 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 25 24
Measure Type: Count of Participants
Unit of Measure: Participants
15
  60.0%
15
  62.5%
8.Secondary Outcome
Title Viral Shedding of RSV-A Memphis 37b in Nasal Samples in Terms of Duration, for Double-blind Palivizumab or Placebo (Part 2).
Hide Description Estimation of the duration of viral shedding by the number of days with quantifiable qRT-PCR measurements in nasal samples starting 2 days post viral challenge (Day 2) up to the end of quarantine.
Time Frame From Day 2 to Day 12 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 25 23
Mean (Standard Deviation)
Unit of Measure: days
2.84  (3.01) 2.61  (2.98)
9.Secondary Outcome
Title Viral Shedding of RSV-A Memphis 37b in Nasal Samples in Terms of Time to Peak Viral Load, for Double-blind Palivizumab or Placebo (Part 2).
Hide Description Estimation of the duration of viral shedding by the time to peak viral load of RSV by quantifiable qRT-PCR.
Time Frame From Day 2 to Day 12 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 22 16
Mean (Standard Deviation)
Unit of Measure: days
7.21  (2.98) 7.03  (2.35)
10.Secondary Outcome
Title Viral Shedding of RSV-A Memphis 37b in Nasal Samples in Terms of Peak Viral Load, for Double-blind Palivizumab or Placebo (Part 2).
Hide Description Peak viral load of RSV-A Memphis 37b as defined by the maximum viral load determined by quantifiable qRT PCR measurements in nasal samples starting 2 days post viral challenge (Day 2) up to the end of quarantine.
Time Frame From Day 2 to Day 12 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 25 24
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
3.66  (2.42) 3.11  (2.65)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-blind Placebo (Part 2), Double-blind Palivizumab (Synagis™) (Part 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4868
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Total Symptom Score (TSS)-Time Curve (AUC) Collected Daily in the Participant Symptom Diary Card
Hide Description Mean TSS values (collected daily in the symptom diary card) over time. Symptoms were collected using the hVIVO (services provider) symptom diary card. Several symptoms (such as runny nose, sore throat, earache, etc) in the 13-item questionnaire were graded on a scale of 0-3 (grade 0: No symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: Quite bothersome most or all of the time, and it stops me participating in activities). Shortness of breath and wheeze have an additional grade 4: Symptoms at rest. The total symptom score (TSS) was determined as the sum of the symptom scores ranging from 0.0 (min) to 41(max) [or a maximum of 41x11.33=464.67 depending on what the reviewer is asking] using a 13-items self-reported diary card. 11.33 is the number of days symptom diary cards were included (Day +1 morning dairy card to Day 12 morning diary card). Higher scores mean worse outcome.
Time Frame From two days post viral challenge (Day 2) to the end of quarantine (Day 12) in Part 2 on nasal samples collected twice daily.
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 25 24
Mean (Standard Error)
Unit of Measure: Total Symptom Score scale-points*day
13.84  (14.72) 7.27  (9.03)
12.Secondary Outcome
Title Peak Symptom Scores
Hide Description

Peak symptom scores for symptoms collected daily in the participant symptom diary card.

Symptoms (such as runny nose, sore throat, earache, etc) were collected using the 13-item hVIVO symptom questionnaire and were graded on a scale of 0-3 (grade 0: No symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: Quite bothersome most or all of the time, and it stops me participating in activities). Shortness of breath and wheeze have an additional grade 4: Symptoms at rest. The total symptom score (TSS) was determined as the sum of the symptom scores ranging from 0.0 (min) to 41(max) [or a maximum of 41x11.33=464.67 depending on what the reviewer is asking] using a 13-items self-reported diary card. 11.33 is the number of days symptom diary cards were included (Day +1 morning dairy card to Day 12 morning diary card). Higher scores mean worse outcome.
Time Frame From Day 2 to Day 12 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 25 24
Mean (Standard Error)
Unit of Measure: score on a scale
4.16  (3.45) 2.54  (3.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-blind Placebo (Part 2), Double-blind Palivizumab (Synagis™) (Part 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0403
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Secondary Outcome
Title Total Weight of Nasal Discharge Produced
Hide Description Nasal Discharge Collection from Paper Tissues by means of the total weight of nasal discharge produced.
Time Frame From Day 1 to Day 12 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 23 21
Mean (Standard Error)
Unit of Measure: g
22.23  (41.52) 7.66  (14.92)
14.Secondary Outcome
Title Total Number of Tissues Used by Participants
Hide Description Nasal Discharge Collection from Paper Tissues by means of the total number of tissues used.
Time Frame From Day 1 to Day 12 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 25 24
Mean (Standard Error)
Unit of Measure: tissues
32.04  (42.74) 20.38  (21.88)
15.Secondary Outcome
Title Number of Participants With Laboratory-confirmed Virus-like Illness (Variant 1) Using Viral Shedding Variant 1, for Double-blind Palivizumab or Placebo (Part 2).
Hide Description Illness Post-viral challenge measured by means of the proportion of participants with any symptom ≥grade 1 for the evaluable population.
Time Frame From Day 2 to Day 12 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 25 24
Measure Type: Count of Participants
Unit of Measure: Participants
11
  44.0%
5
  20.8%
16.Secondary Outcome
Title The Occurrence of Laboratory-confirmed Virus-like Illness (Variant 1) Using Viral Shedding Variant 2, for Double-blind Palivizumab or Placebo (Part 2).
Hide Description Illness Post-viral challenge measured by means of the proportion of participants with any symptom ≥grade 1 for the evaluable population.
Time Frame From Day 2 to Day 12 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 25 24
Measure Type: Count of Participants
Unit of Measure: Participants
11
  44.0%
5
  20.8%
17.Secondary Outcome
Title The Occurrence of Laboratory-confirmed Virus-like Illness (Variant 2) Using Viral Shedding Variant 1, for Double-blind Palivizumab or Placebo (Part 2).
Hide Description Illness Post-viral challenge measured by means of the proportion of participants with any symptom ≥grade 1 for the evaluable population.
Time Frame From Day 2 to Day 12 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 25 24
Measure Type: Count of Participants
Unit of Measure: Participants
13
  52.0%
11
  45.8%
18.Secondary Outcome
Title The Occurrence of Laboratory-confirmed Virus-like Illness (Variant 2) Using Viral Shedding Variant 2, for Double-blind Palivizumab or Placebo (Part 2).
Hide Description Illness Post-viral challenge measured by means of the proportion of participants with any symptom ≥grade 1 for the evaluable population.
Time Frame From Day 2 to Day 12 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 25 24
Measure Type: Count of Participants
Unit of Measure: Participants
15
  60.0%
14
  58.3%
19.Secondary Outcome
Title Cmax
Hide Description Evaluation of Palivizumab PK levels throughout the study, by means of Cmax after intravenous administration of Palivizumab.
Time Frame Before the start of infusion; at end of infusion, 15 minutes and 0.5, 1, 4, 8, and 12 hours after infusion; and at 1, 2, 3, 7 and 12 days after infusion (Part 1) or at 1, 2, 3, 7, 13, 21, and 29 days after infusion (Part 2)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated had at least 1 post-dose PK result; therefore, all participants were included in the PK analysis population. One participant had an interrupted IV infusion of Palivizumab but received the complete dose of 8 mg/kg.
Arm/Group Title Open-label Palivizumab (Part 1) Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 5 0 23
Mean (Standard Deviation)
Unit of Measure: μg/mL
262  (35.6) 283  (46.5)
20.Secondary Outcome
Title Tmax
Hide Description Palivizumab PK levels throughout the study, by means of Tmax after intravenous administration of Palivizumab.
Time Frame Before the start of infusion; at end of infusion, 15 minutes and 0.5, 1, 4, 8, and 12 hours after infusion; and at 1, 2, 3, 7, and 12 days after infusion (Part 1) or at 1, 2, 3, 7, 13, 21, and 29 days after infusion (Part 2)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated had at least 1 post-dose PK result; therefore, all participants were included in the PK analysis population. One participant had an interrupted IV infusion of Palivizumab but received the complete dose of 8 mg/kg.
Arm/Group Title Open-label Palivizumab (Part 1) Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg or 15mg/kg, administered at a rate of 1mL/min

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 5 0 23
Median (Full Range)
Unit of Measure: hours
0.90
(0.57 to 1.70)
0.92
(0.53 to 1.77)
21.Secondary Outcome
Title Safety Adults: Number of Participants With Adverse Events (AEs)
Hide Description Incidence of AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs) and; drug-related or challenge-virus related TEAEs and SAEs
Time Frame From Day 1 to Day 18 in Part 1 and from Day 1 to Day 28 in Part 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population: All participants randomly assigned to study intervention and who took a dose of study intervention, regardless of whether they received the challenge virus or not.
Arm/Group Title Open-label Palivizumab (Part 1) Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 6 25 25
Measure Type: Number
Unit of Measure: participants
Any AE 0 12 14
Any TEAE 0 12 14
Any TEAE related to the study drug 0 1 4
Any TEAE related to the challenge virus 0 5 8
Any SAE 0 0 1
Any SAE leading to study discontinuation 0 0 0
Any SAE related to the study treatment 0 0 0
Any SAE related to the challenge virus 0 0 1
Any death 0 0 0
22.Secondary Outcome
Title Immunogenicity: Number of Participants Positive for Anti-palivizumab Antibody (ADA)
Hide Description Determination of the incidence of anti-palivizumab ADA (number and percent of participants tested positive for anti-palivizumab ADA). ADA positive participant: baseline negative and any sample after treatment positive, or baseline positive and titre increased 4- to 9-fold after treatment) before the dose of palivizumab and at scheduled post-dose assessments.
Time Frame Part 2: prior to infusion with Palivizumab and 7, 13, and 29 days post Palivizumab infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population: All participants randomly assigned to study intervention and who took a dose of study intervention, regardless of whether they received the challenge virus or not.
Arm/Group Title Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description:

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame Day 1 to Day 28
Adverse Event Reporting Description Adverse events were coded using the most current version of the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class, preferred term, and treatment group for the number of AEs reported and the number and percentage of patients reporting each AE.
 
Arm/Group Title Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Hide Arm/Group Description

Sodium Chloride 0.9% Solution (Normal Saline)

Placebo: Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Sterile vial 50mg/0.5mL

Palivizumab: Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg, administered at a rate of 1mL/min

RSV-A Memphis 37b virus: Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
All-Cause Mortality
Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/25 (0.00%)    
Hide Serious Adverse Events
Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      1/25 (4.00%)    
Cardiac disorders     
Myocarditis † 1 [1]  0/25 (0.00%)  0 1/25 (4.00%)  1
1
Term from vocabulary, MedDRA 23.0
†
Indicates events were collected by systematic assessment
[1]
Considered by the investigator to be probably related to challenge virus inoculation.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Double-blind Placebo (Part 2) Double-blind Palivizumab (Synagis™) (Part 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/25 (48.00%)      14/25 (56.00%)    
Investigations     
Alanine Aminotransferase Increased † 1  6/25 (24.00%)  6 9/25 (36.00%)  9
Aspartate aminotransferase increased † 1  4/25 (16.00%)  4 5/25 (20.00%)  5
Musculoskeletal and connective tissue disorders     
Back Pain † 1  2/25 (8.00%)  2 0/25 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash † 1  0/25 (0.00%)  0 2/25 (8.00%)  2
1
Term from vocabulary, MedDRA 23.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is >60 days but < or= 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication if it does not include any reference to the Sponsor, any Study Identifier, or any Property or other Confidential Information of the Sponsor, other than the anonymized Non-drug data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Trials
Organization: mAbxience Research SL
Phone: +34917711500
EMail: susana.millan@mabxience.com
Layout table for additonal information
Responsible Party: mAbxience Research S.L.
ClinicalTrials.gov Identifier: NCT04540627    
Other Study ID Numbers: MB05-P-01-20
First Submitted: July 24, 2020
First Posted: September 7, 2020
Results First Submitted: June 22, 2021
Results First Posted: October 4, 2021
Last Update Posted: October 4, 2021